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Clinical Trials/NCT00082290
NCT00082290
Completed
Phase 2

Massage for the Treatment of Pain in Cancer: A Randomized Phase II Study

Memorial Sloan Kettering Cancer Center1 site in 1 country92 target enrollmentStarted: May 2003Last updated:
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ConditionsPainUnspecified Adult Solid Tumor, Protocol Specific

Overview

Phase
Phase 2
Status
Completed
Enrollment
92
Locations
1
Primary Endpoint
reduction in pain
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

RATIONALE: Massage therapy may help lessen pain caused by cancer.

PURPOSE: This randomized phase II trial is studying how well massage therapy works in treating patients with cancer pain.

Detailed Description

OBJECTIVES:

  • Determine whether the effects of massage therapy in patients with cancer pain are sufficiently promising to warrant a definitive trial.
  • Determine the feasibility of a definitive trial.

OUTLINE: This is a randomized, controlled, pilot study. Patients are stratified according to in-patient status (yes vs no) and first baseline pain score ≥ 7 (yes vs no). Patients are randomized to 1 of 3 treatment arms.

  • Arm I (massage therapy): Patients receive a light touch ("Reiki") massage over 45 minutes.
  • Arm II (volunteer visit control): Patients receive a 45-minute visit from a trained volunteer who will be available to sit quietly or talk with the patient to discuss issues of concern, as desired by the patient. Volunteers will not touch the patient except to pat their shoulder or briefly hold their hand.
  • Arm III (quiet time control): Patients receive 45 minutes of quiet time. Pain and mood are assessed at baseline, immediately after treatment, at 6 hours and 24 hours after treatment, and then daily for the next 5 days after treatment.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 120 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

reduction in pain

Time Frame: 24 hours after treatment

A mean change score equivalent to 2 points will be considered the minimum clinically significant reduction in pain

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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